BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2060131 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-06156
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PACING OUTPUT OF THE RELATED DEVICE WAS INCREASED, AND A FOLLOW-UP APPOINTMENT WAS SCHEDULED TO FURTHER EVALUATE THE LEAD. THIS REPORT WILL BE UPDATED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING LOSS OF CAPTURE DUE TO AN INCREASING PACING THRESHOLD. IT WAS ALSO REPORTED THE PACING IMPEDANCE HAD DECREASED. NO SPECIFIC ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR 1860| 1851| 0148